Safety & Effectiveness of the PXL-Platinum 330 System for CXL Using Riboflavin Solution

Inclusion Criteria

• •8 years of age or older
• •Signed written informed consent
• •Willingness and ability to comply with schedule for follow-up visits
• •Contact Lens Wearers Only:
• •Removal of contact lenses (if applicable) for the required period of time prior to the screening refraction: Soft, discontinue 3 days; Soft Extended Wear, discontinue 3 days; Soft Toric, discontinue 3 days; Rigid gas permeable, discontinue 2 Weeks (subjects who cannot function without wearing their contact lenses, may forgo discontinuation of contact lenses)
• •And one or more of the following:
• •Presence of central or inferior steepening.
• •Axial topography consistent with keratoconus, post-surgical ectasia, or pellucid marginal degeneration
• •Presence of one or more findings associated with keratoconus or pellucid marginal degeneration, such as: Fleischer ring, Vogt's striae, Decentered corneal apex, Munson's sign, Rizzutti's sign, Apical Corneal scarring consistent with Bowman's breaks, Scissoring of the retinoscopic reflex, Crab-claw appearance on topography
• •Steepest keratometry (Kmax) value ≥ 47.20 D
• •I-S keratometry difference \> 1.5 D on the Pentacam/Orbscan map or topography map
• •Posterior corneal elevation \>16 microns
• •Thinnest corneal point \>300 microns